Medical Device Nonvisual Accessibility Act of 2024

Summary

Medical Device Nonvisual Accessibility Act of 2024 This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA). Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.) A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold. However, the FDA may waive the bill's requirements for a device upon a showing that applying the standards would fundamentally alter the nature of the device or create an undue hardship for the manufacturer. The bill also does not apply to devices that are intended solely for use by a health care provider or in a setting outside the home.

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Timeline

1. 18 January 2024

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 18 January 2024

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 18 January 2024 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 18 January 2024

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 18 January 2024

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 18 January 2024

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Hassan, Margaret Wood [D-NH] · D · Sponsor
• Sen. Braun, Mike [R-IN] · R · Sponsor
• · sshr00 · Standing

Related records

• related to → Medical Device Nonvisual Accessibility Act of 2023